ES2282246T3 - Vascular embolia prevention device using filters. - Google Patents

Vascular embolia prevention device using filters. Download PDF

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Publication number
ES2282246T3
ES2282246T3 ES01922337T ES01922337T ES2282246T3 ES 2282246 T3 ES2282246 T3 ES 2282246T3 ES 01922337 T ES01922337 T ES 01922337T ES 01922337 T ES01922337 T ES 01922337T ES 2282246 T3 ES2282246 T3 ES 2282246T3
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Spain
Prior art keywords
filter
element
characterized
system according
displacement
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ES01922337T
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Spanish (es)
Inventor
Peter Besselink
Anthony T. Don Michael
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Peter Besselink
Anthony T. Don Michael
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Family has litigation
Priority to US18817900P priority Critical
Priority to US188179P priority
Application filed by Peter Besselink, Anthony T. Don Michael filed Critical Peter Besselink
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=22692060&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2282246(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01Filters implantable into blood vessels
    • A61F2/013Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stending
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01Filters implantable into blood vessels
    • A61F2002/018Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • A61F2230/0006Rounded shapes, e.g. with rounded corners circular
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0067Three-dimensional shapes conical
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0093Umbrella-shaped, e.g. mushroom-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0003Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

System to prevent embolism and micro-embolism in a vascular system, adapted to be introduced into a patient's blood vessel, said system comprising radially expandable filter elements from a closed state to an open state, characterized in that the arrangement of the filter comprises: - a first element and a second filter element with a structured filter surface to prevent the passage of particles and allow the passage of blood, - where said first filter element (4, 44, 102, 160) it has millipores and is coupled to a first elongated displacement element (2, 200) to displace said first filter element, - wherein said second filter element (14, 190) is coupled to a second displacement element (12, 210) to displace said second filter element (14, 190), - a first sheath (1) surrounding said first displacement element (2) to position the first filter element (4) in its state closed at its desired location inside the blood vessel, said first filter element (4) being able to be removed from said first sheath (1) to deploy radially to its open state by using said first displacement element (2), - a second sheath (10, 170) surrounding the displacement elements (2, 200; 12, 210) to position the second filter element (14, 190) in its closed state in its desired location inside the blood vessel, said second filter element (14, 190) being able to be removed from said second sheath (10 ) to deploy radially to its open state by using said second displacement element (12, 210), where at least one of said filter elements can be displaced into said second sheath (10) to contract at least one radially of said filter elements until their closed state.

Description

Vascular embolism prevention device It uses filters.

Technical sector

The present invention relates to medical procedures performed on blood vessels, especially in arteries.

State of the art

This invention relates more specifically to systems and methods that involve angioplasty and / or angioplasty with "stent", in which protection against the free embolic material.

These procedures are performed to eliminate blockages or blockages in arteries and thus relieve states under which life is in danger. The procedures currently employees result in the fracture or disintegration of the obstructive material and if the resulting particles or debris they flow downstream into the circulatory system, they could produce blockages in smaller arteries or their ramifications microscopic called microcirculation, downstream of the place of treatment The result may be new states under which endangers life, including stroke.

Several systems and techniques have already been proposed to remove this waste from the circulatory system in order to prevent waste from causing damage. These techniques involve temporary obstruction of the artery, in a downstream place of the obstruction, by means of an element (for example, a balloon), and then aspirating waste and blood from the place of treatment. Although such techniques can effectively solve the problem indicated above, require that blood flow through of the artery is clogged, causing complete cessation or at minus a substantial reduction in blood flow volume, over a period of time that may be important for example for organ survival, since the time limit for Brain is measured in seconds and for the heart in minutes.

Although filters have been used, they present the limitation that either obstruct blood flow or They cause microembolism due to a fixed pore size. Further, collected waste can leave the filter when it is closed and cause a stroke. When removing a basket / filter with particles trapped into a catheter, waste particles they can leave the device since the volume is reduced so important. During this withdrawal operation, the filter is no longer it covers the entire cross section of the artery, so that the leaking particles can flow freely around the outer edge of the filter and move distally through the artery.

The patent US-A-5 108 419 describes a system composed of a plurality of filters arranged in line with each other along with elements to allow filters to expand and get. However, the entire structure associated with the filter elements is only operative to expand or contract all elements in unison, which has proved to be ineffective  so that the residues are completely trapped between the filters There is no possibility, with the system described in this reference, to expand or contract any of the filters so independent of the others nor is described in this reference the I wish to do it.

It is the object of the invention to enable a treatment that can produce emboli.

As described in this application, the system defined in claim 1 achieves the result intended by introducing the system into a blood vessel, radially expanding one of the filter elements, and then radially expanding another filter element so that cooperate with the previously expanded filter element to catch plungers, after which both filter elements are they contract and the system withdraws.

In order to perform this operation, it is necessary, obviously, that the two filter elements are movable between its open and closed state independently the one of the other.

The invention also relates to a device. combined supply / post-dilation for "expandable" stents.

Normally, the supply of stents self-expandable is done with a case of independent supply that is pulled back to free from its cover to the "stent" compressed and allow it to unfold. Yes the stent does not unfold at full size, because the reaction forces of the artery wall and the site of the injury are too high, should be able to be expanded even further by an additional post-dilation procedure. Therefore, an independent catheter is needed post-dilation that must be placed in place of the lesion provided with the stent and then inflated until Get full size. This is an extra stage of the procedure that It requires some time.

Brief Description of the Invention

The present invention provides a method and a device to prevent waste from escaping from the place of treatment in a blood vessel and, more specifically, to prevent embolism, by installing at least one filter with suitable millipores, specific to be used current below, and possibly such a filter downstream of the place of treatment in a blood vessel, and through the manipulation of said filters in a way that guarantees that all waste originating at the treatment site or that reflux by closing the filters will be removed from the system vascular by physical removal of filters and / or by aspiration.

For example, an embodiment of the invention can be a system multi-stage, with two filters for example, compound of a first filter to filter blood flow and of a second filter to trap debris from the first filter.

The invention also relates to a system of stent catheter self-expanding that combines the functions of supply from a central cover and from post-dilatation, including a catheter system provided with an inflatable outer section surrounding the cover in the distal end section of the catheter. The first stage in a procedure that uses this system is the release of "stent" removing it from the case and withdrawing backwards from the catheter a distance that is at least equal to the length of the "stent" Then, the catheter moves forward again until the inflatable section aligns again with the "stent" For post-dilatation, the section inflatable is inflated and the place of injury and the stent is They expand even more.

In an embodiment of the invention, the central lumen of the supply sheath, from which the "stent" is reinforced to prevent crushing by the hydraulic pressure of the post-dilatation balloon that surrounds. The reinforcement of this sheath can be obtained by giving the catheter adequate rigidity at its distal end, for example by a thicker catheter at said end. This can make the supply case is too rigid, which can be a disadvantage for use in tortuous arteries.

Therefore, the invention uses a cover of more flexible supply that cannot be crushed thanks to the use of a separate reinforcement. A pre-dilatation balloon can be aligned with the supply case and inflated until it is full the lumen of this supply case. Thus, a provision concentric two balloons, separately inflatable, provides a strong post-dilation device that is extremely flexible in deflated state.

A single common guide wire is used to bring the catheters to the site of the injury and the catheter pre-dilation acts as a guide for the post-dilation balloon / supply case "stent" When removing the pre-dilatation catheter, leaving the inflated supply catheter in place, a proximal occlusion system with a large working channel (the cover of supply). In combination with a means of distal occlusion, for example a distal balloon, a closed chamber is created in the artery to which can be reached through a series of instruments for this purpose of inspection, treatment and cleaning / aspiration.

Brief description of the figures

Figure 1 is a simplified illustration that shows a first component of a system according to the invention.

Figure 2 is a simplified illustration that shows the first component of Figure 1 in an expanded state, associated with a treatment device.

Figure 3 is an image similar to that of the Figure 1 showing the first component and a second component of a system according to the invention.

Figure 4A and 4B are illustrations simplified showing two basic embodiments of the invention.

Figures 5, 6 and 7A are elevation views and section of several alternative embodiments of components of the filter of a system according to the invention.

Figure 7B is a plan view of the mode of embodiment of figure 7A.

Figures 8, 9 and 10 are illustrations simplified that show specific procedures that can be carried out with a system according to the invention.

Figure 11 is an elevation view in another way of realization of a filter component of a system according to the invention.

Figure 12 is a side view of a component of another embodiment of a system according to the invention, including a filter in its bent state.

Figure 13 is a view similar to that of the Figure 12, showing the filter in its expanded state.

Figure 14 is a view from one end of the component with the filter in its expanded state.

Figure 15 is a side and sectional view, simplified, which shows the other embodiment of a system in a blood vessel with two filters of the type indicated in the Figures 12-14.

Figure 16 is a view similar to that of the Figure 15 showing a modified form of construction of the system indicated in Figure 15.

Figures 17-27 are Simplified illustrations showing successive stages in a angioplasty procedure and stent placement which uses an embodiment of a system according to the invention.

Figure 17 shows a guide wire introduced into an injured artery.

Figure 18 shows a guide catheter with a distal protection means, introduced into the lesion on the guide wire

Figure 19 shows how the means of protection distal is deployed until it reaches the walls of the arteries

Figure 20 shows a catheter of predilatation, which has been introduced above the catheter of guide, in its predilatation position with an inflated balloon in the area of the injury. Figure 20 also shows a supply case with a distal inflatable section, which holds a stent tablet, which has been introduced above the catheter of predilatation provided with the globe.

Figure 21 shows how the balloon deflates predilatation and travels through the site of the injury, in addition of the semi-deployed stent once it has been taken to the area of the injury.

The two balloons are shown in Figure 22 aligned and introduced in the stent.

In Figure 23, the balloon of pre-dilation is inflated to create a support for The inflatable supply case.

In Figure 24 the inflatable supply case It is inflated to perform the final angioplasty and achieve full stent deployment.

In Figure 25, the catheter is removed from pre-dilatation provided with a body balloon patient while the inflated sheath is still in place.

In Figure 26, the artery chamber between the distal protection means and the inflated sheath is watered to Remove or trap all waste.

In Figure 27, the cover is deflated and the medium distal protection folds, thereby allowing its withdrawal of the artery, leaving only the stent placed.

Detailed description of the invention

The invention provides a method and system. novel to enclose and eliminate waste from a blood vessel, thus avoiding embolism in the vascular system.

A first step of an embodiment of a method according to the invention includes placing a first filter of particles in the blood vessel downstream of the site of treatment.

Figure 1 is an elevational view and section of a first unit of a protective system according to the invention for Carry out the first step. This unit consists of a case (1), a hollow guide wire (2) and a distal filter of particles (4).

The filter (4) can have any shape, a conical shape for example, as shown, and built so that be radially expandable from a radially state compressed, shown in solid lines, to a radially state expanded, shown in dashed lines in 4 '. Preferably at least a part of the filter (4) is composed of a material elastically deformable that autonomously assumes the state radially expanded shown in 4 'when not constrained. He filter (4) can be shaped by means of suitable conformation, to open with a top flared made of highly elastic material (for example, in metal with memory "nitinol").

The cover (1) serves to hold the filter (4) in the radially compressed state during filter transport (4) to and from the place of treatment.

The filter (4) has a tip or vertex that is fixed to the guide wire (2). The guide wire (2) extends from a proximal end that will always be outside the body of the patient and accessible to the doctor at a distal end that extends after the vertex.

The guide wire (2) is preferably a hollow tube whose distal end is used, according to the invention, as a pressure sensor which is connected to a pressure monitoring device (5) connected to the end proximal guide wire (2). The device (5) is exposed a, and detects, through the longitudinal passage or conduit of the tube (2), the pressure adjacent to the distal end of the guide wire (2).

Preferably, the device monitoring (5) is detachably attached to the end proximal guide wire (2). The device (5) will be removed, for example, when the guide wire (2) is to be used for guide some other component of the device into the interior of the blood vessel after insertion of the first unit into a blood vessel, as will be described in more detail below.

According to a practical embodiment of the invention, the sheath (1) has an outer diameter of 1 to 1.5 mm and the wire (2) has an outside diameter of 0.014-0.018 inches (approximately 0.5 mm) and is  dimensioned so that during insertion it does not disturb the obstruction to be removed. The filter (4) can be sized to expand to an outside diameter of more than 1 mm, and preferably more than 10 mm. This dimension will be selected. to be approximately as large as the diameter of the vessel a try.

Before insertion into a blood vessel, the filter (4) is placed in the sheath (1) as indicated in the Figure 1. Then, in a conventional preliminary step, the wall of the blood vessel is pierced by a hollow needle, it insert a preliminary guide wire (not shown) into the vessel blood through the needle, the needle is removed, the blood vessel opening and a guide catheter (not shown) is passed over the preliminary guide wire to the blood vessel to treat The distal or leading end of the guide catheter is placed at an appropriate point ahead of the obstruction to be treated and the preliminary guide wire is removed. Then the guide wire (2) and the sheath (1), with the filter (4) in place, it they enter the blood vessel in the direction of flow blood, in a conventional way through the guide catheter, until the filter (4) is in the desired position in the vessel, usually downstream of the obstruction to be treated. The Introduction through the guide catheter facilitates precise passage of the filter (4) and the cover (1) preventing them from twisting and allowing easier positioning, as well as reducing the risk of evicting clot particles from the obstruction, which as a rule it is plaque. Then the surgeon maintains the wire (2) motionless and remove the sheath (1), which is sufficiently  long to be accessible to the surgeon from outside the body of the patient, until the sheath (1) separates from the filter (4), which can be expanded below to adopt the configuration shown in 4 '. Then, the cover (1) can be completely withdrawal from the glass If necessary, the proximal end of the sheath (1) It can be closed, usually during its extraction.

A second step of a method according to the invention It involves performing the desired medical treatment in the region upstream of the filter (4), where said region, according to the Figure 2, is located under the filter (4). Said treatment it may be in order to eliminate a blockage in a glass blood (6), and this may involve any procedure of known angioplasty, any disintegration procedure of known obstruction, or any observation procedure (vision) that uses ultrasound, laser radiation, placement of stent, etc. or any mechanical cutting procedure, etc. The device to perform this function can be guided to the place of treatment being displaced along the guide wire (2).

For example, this device can be a ultrasonic device as described in Patent No. US4870953. This device has an outlet end (8) provided of a bulbous tip that applies ultrasonic vibrations to the obstruction material (for example clot or plaque). The end of exit (8) can be guided to the place of obstruction of any conventional way on the wire (2), however you can facilitate the operation by providing the outlet end (8) with a ring (9) or clip that fits around the guide wire (2) before the outlet end (8) is introduced into the vessel blood (6).

Once the device has been placed in the place of treatment is activated to perform the desired treatment, in this case, the disintegration of the plaque or clot, usually by pre-dilation, placement of the stent and dilation of the stent. Once the  treatment, the treatment device is removed from the vessel blood

A third step of a method according to the invention includes the placement of a second particle filter in the vessel blood, upstream of the first filter (4) and preferably upstream of the treatment site. It is done sliding the guide wire (2) through a hole in a second filter (14), described below, adjacent to a guide wire (12) that carries the second filter.

Figure 3 is an elevational view and section of a second unit of the protection system according to the invention to carry out the third step.

This second unit consists of a second tube or sheath (10), a second guide wire (12) and a filter of proximal particles (14). The cover (10) can have a diameter of the order of 3 mm. At the moment this unit is inserted in the blood vessel, the filter (4) remains placed in the vessel blood, in an expanded state as indicated by 4 'in the Figure 1, as does the hollow guide wire (2).

The proximal filter (14) has a vertex provided with a ring (16) through which the wire is inserted guide (2) when the second unit is still placed outside the patient's body, in order to guide the second unit in the vessel blood to the treatment site. The second guide wire (12) is fixed to the ring (16).

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Before the introduction into the body of the patient, the filter (14) is installed in the sheath (10) in the manner illustrated in Figure 3. Then, the second unit is placed over guide wire 2 and carried to the blood vessel until The desired location.

Once the second unit has been placed in the desired place, the proximal filter (14) remains motionless holding the end of the guide wire (12) that is outside of the patient's body, while the case is being retracted (10). When the filter (14) is released from the distal end of the sheath (10), the filter (14) expands radially in the configuration shown in 14 'to cover the filter (4). This step is completed when the Filter (14) is fully radially expanded.

Given the porous nature of the filters (4) and (14), a reasonable volume of blood flow can be maintained in the blood vessel when filters are deployed.

Before the introduction of the filter (14), all residue produced by the treatment performed in the second stage will be transported by the blood that flows to and through the radially expanded filter (4), where the waste will tend to stay. During and after the introduction of the filter (14) and the expansion of the filter (14) to the configuration shown in 14 ', aspiration can be applied to the region between the filters through of the cover (10). This will help ensure that waste remain trapped between the two filters.

So, in a fourth step, the waste is removed from the blood flow (6) by pulling the wire (2) so that pull the filter (4) and make it come in contact with the filter (14), and then refolding both filters in the sheath (10) by stretching the guide wires (2) and (12), therefore removing the assembly of filters (4) and (14) to the cover (10). The cover (10) with filters in its interior is then removed through the guide catheter (not shown), which is subsequently removed from the blood vessel using standard procedures. These operations are performed pulling the guide wire (2) at its proximal end, located outside the patient's body, while maintaining initially the guide wire (12) still until the filter (4) it is coupled to the filter (14). Then both guide wires (2) and (12) are stretched to fold the filters inside of the cover (10). Finally, both guide wires and the sheath (10) are removed as a unit of the blood vessel. During Any part, or throughout this step, can be applied aspiration to filters (4) and (14) through the cover (10).

Figures 4A and 4B are illustrations simplified that show two possible arrangements for a game of filters (4) and (14). The arrangement shown in Figure 4 A corresponds to that shown in Figures 1, 2 and 3. The arrangement shown in Figure 4B differs in that the filter (4) is inverted  in relation to the orientation that appears in Figures 1, 2, 3 and 4A. The filter arrangement shown in Figure 4A is applicable to segments of arteries that are short and not tortuous. Figure 4B shows an optional filter arrangement for longer segments of arteries especially if they are tortuous

When using the arrangement shown in the Figure 4B, filters (4) and (14) are placed in the vessel blood by the first and third steps described previously. In order to remove the filters, the guide wire (2) it is stretched to place the filter (4) in a position where its larger diameter end has been introduced at the end of larger filter diameter (14). Then, when both filters are inserted in the case (10), the filter (14) is folded by its contact with the cover (10) and the filter (4) folds by its contact with the inside of the filter (14). In this form of construction, the filter (14) has an expanded diameter at least slightly higher than the filter (4).

The arrangement illustrated in Figure 4B offers the advantages that in the first stage the filter (4) can be removed from the holster (1) a little easier and, once the filter (4) has been expanded, all waste produced by the operation performed in the second step will tend to focus close of the vertex of the filter (4), far from its line of contact with the blood vessel wall

An example of embodiment of the filter (4) is indicated in greater detail in Figure 5. This mode of embodiment consists of a frame or frame, composed of a ring (22) of small diameter at the vertex of the filter (4) and a plurality of struts (26) extending between the rings (22, 24). The frame is preferably made of one piece relatively thin and metal with memory, which is fine Known for the technique. An example of such a metal is nitinol. He frame is built to normally assume a state radially expanded, such as indicated in 4 'in Figure 1, but to be easily deformed so that it can be retracted or radially compressed in the sheath (1).

The frame is covered on its surface exterior of a thin sheet (28) or membrane of a material of suitable filter that has pores sized according to principles of the technique to protect the organs downstream from the area of treatment. Pore dimensions are chosen to allow a reasonable flow of blood to the organs downstream of the place of treatment when filters are placed trapping the same time waste particles of a size capable of causing damage to these organs. The desired filtering action will be achieved with a pore size of the order of 50 µm to 300 µm. It allows to use different sizes of milliporo to optimize or either blood flow or protection against embolism. The larger pores will be used in situations where must maintain a higher blood flow and the leakage of small Waste particles are medically acceptable.

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Figure 6 is a view similar to that of the Figure 5 and shows a suitable embodiment of the filter (14), shown here essentially in its expanded state. As the filter (4), the filter (14) includes a frame or frame, with a ring (32) of reduced diameter at its apex, a ring (34) of larger diameter at its largest diameter end and a plurality of struts that extend between the rings (32, 34). The filter (14) it is completed with a filter sheet or membrane (38), fixed to the outer surfaces of the struts (36). The ring (32) offers a passage for the guide wire (2), the step being sized to allow the filter (14) to move freely along the guide wire (2). The guide wire (12) is fixed to the outer surface of the ring (32).

Figures 7A and 7B are, respectively, a elevation and section view and an otherwise plan view of realization of a distal filter (44) that can be used in filter place (4). This embodiment includes, as the filter (4), a ring (22) of small diameter, a ring (24) of large diameter and a plurality of struts (26), with a sheet (28) filter attached to the outer surfaces of the struts (26). Here again, the ring (22) has an opening to receive the guide wire (2), which will be fixed to the ring (22).

The filter (44) is also provided with a second ring (46) of small diameter and a second series of struts (48) that extend between the rings (24, 46). He ring (46) has an opening with a diameter greater than that of guide wire (2), so that the ring (46) can be moved with  relation to the guide wire (2).

All filter parts (44), except the membrane (28), as the corresponding parts of the filters (4, 14), can be made of a piece of metal with memory that is been processed to deform the filter towards its configuration radially expanded. All these components are what thin enough to allow the filter to be easily folded radially within its respective case (1) or (10). He filter (44) will be mounted so that its vertex points at distal direction, that is, the cone formed by the struts (26) and the filter sheet (28) has an orientation that is opposite to the of the filter (4).

The filter (44) is put in its state radially expanded essentially in the same way as the filter (4). When the filter part is in the desired situation in the blood vessel, the sheath (1) will be folded in order to allow The filter (44) expands radially. When the filters, the guide wire (2) is pushed proximally until the bottom of the filter (44), composed of the ring (46) and strut (48), is received either totally or partially in the filter (14). Then, both guide wires (2, 12) can be stretched in the proximal direction in order to fold the filters in the cover (10). During this operation, the ring (46) has a some freedom of movement in relation to the guide wire (2), which will help facilitate radial contraction of the filter (44). Alternatively, or in addition to, the cover (10) can be displaced in the distal direction to assist in the retraction operation.

According to still other alternatives, the rings (22, 46) may be sized so that the guide wire (2) or be fixed to the ring (46) and move longitudinally in relation to the ring (22), or the wire of guide (2) is fixed to both rings (22, 46). On this last case, the contraction and radial expansion of the filter (44) will still be possible in view of the flexibility and deformability of their components.

A system can be used according to the invention, for example, to improve the safety of surgery bypass or bypass. In relation to Figure 8, an example of that surgery involves fixing venous bypass grafts to the aorta (50) from a point just downstream of the valve aortic (52) located between the left ventricle and the aorta of the heart (54). In said procedure, the holes are made (56) in the aorta (50) for the insertion of the current ends above the grafts. The operation of cutting on the wall of the aorta for sewing grafts can produce waste that will be transported by blood flow through the aorta to places in the circulatory system where they can create an embolism in various organs, including the brain.

In relation to Figure 8, the risk of that event can be reduced by introducing a system according to the representation of Figures 1-3, before practice the holes (56), through a subclavian artery (58), which can be accessed through the patient's arm, and of the brachial artery, to place the filters (4, 14) in a position downstream of the location where the holes (56) and to expand those filters so that extend through the blood flow of the aorta. Then, when the holes (56) are made, all waste produced by the cutting operation will be caught, at least initially, inside the filter (4). However, while both filters are being removed inside the tube (10), once the holes (56) have been practiced and possibly after the venous grafts have been sutured to the holes, some residues can leave the filter (4), even if it is being practiced aspiration through the tube (10). If this happens, the waste can be aspirated into the filter (14) to be removed with circulatory system security.

Another example of the use of an agreement system with the invention to capture waste due to a process method is illustrated in Figure 9. A plate tank (62) It is present in the wall of an internal carotid artery (64) just downstream of the junction with an external carotid artery associated (66). A guide catheter (68) is inserted into the artery common carotid (70) and is used as a conduit to introduce all devices required to remove plate (62) and Collect the resulting waste. The catheter (68) carries a balloon of annular lock (72) on its outer surface and is provided with a conduit (not shown) to supply inflation fluid to the balloon (72).

A wire (74) that carries a sensor Doppler flow is introduced into the internal artery (64) to position the flow sensor downstream of the plate (62). Then, the cover (1) (not shown) is introduced to unfold the filter (4) in the external artery (66), as described earlier in the present document, and the balloon (72) is inflated to block flow blood around the catheter (68). Once the filter is deployed (4) and inflated the balloon (72), you can carry out any conventional procedure (for example the one described above with reference to Figure 2) to disintegrate the plate (62).

Next, as described with reference to Figure 3, the cover (12) is moved forward through the catheter (68) to the location indicated in Figure 9, the filter (14) unfolds and expands in the internal artery (66) and aspiration is applied as the filters (4, 14) are folded into the case (10).

In this procedure, from a moment before the disintegration of the plaque (62), the blood flow to through the common carotid artery (70) is blocked by the balloon inflated (72). This results in a retrograde flow in the internal artery (64) back to the external artery (66), where waste transported by blood flow will remain caught in the filter (4). The pressure sensing wire (74) is used to determine collateral pressure, which should always exceed 40 mm Hg. in the carotid When a sufficient period of time, the filter (14) will be deployed to fit the filter (4) and both filters will fold into the case (10) while applying aspiration, possibly through the holster (10). Then the balloon (72) will be deflated, the cover (10) will be removed through the guide catheter (68) and remove the catheter (68).

In another application of the invention, the filters they can pass through a small peripheral artery to the root aortic to trap waste generated during surgery cardiac The device can be used during surgery or It can be implanted for long-term use to prevent migration of blood clots to the brain under certain circumstances, such as during atrial fibrillation.

Another example of procedures that can be carried out with a device according to the invention is illustrated in Figure 10, which shows the position of a device according to the invention to treat an obstruction in an artery (80 or 82) emerging from the pulmonary artery (84) connected to the right ventricle (86) of a patient's heart. He right ventricle communicates with the right atrium (88) of the heart, which is supplied with blood by the veins (90, 92). In that procedure, the covers (1, 10) can be introduced both to through the veins (90 or 92) and then through the atrium (88), ventricle (86) and pulmonary artery (84) in any of the arteries (80 or 82) to be treated. The techniques to guide the covers to The length of the path illustrated are well known in the art. A once placed in the corresponding artery (80 or 82), it will be performed an obstruction removal procedure of the way described above.

Figure 11 shows another representation of a filter component according to the invention in the form general of a basket (102) or cup, made of a layer (104) of a radially compressible and autonomously expandable material, such as for example a memory metal, and a filter sheet (106). The layer (104) can be manufactured by weaving metal wire with memory to form a mesh or screen. The filter sheet (106) It is manufactured in a suitable plastic material, such as polyester, perforated to provide filter pores desired, with the dimensions described above. The bottom of the basket (102) can be fixed to the guide wire (2), of the way of the filter (4) described above, or it may have a circular opening that is slidable along the wire (2), with a second guide wire fixed to the end of the opening, to the way of the filter (14) as described above. Each of such baskets (102) will be used in the same way as each of the respective filters (4, 14) and will be sized to spread through the blood vessel at the place where you are going to use the system

The procedures described above are merely examples of the many procedures that can be assisted with the use of the system according to the present invention and other uses will be duly apparent to medical professionals It should also be clear that the examples shown in the drawings are represented schematically. For example, the shape of the ring (24) in Figures 5, 7A and 7B It appears as a circle. However, for a ring that has to be folded to allow the filter to be introduced into the case, it would be more logical to give it a slightly wavy shape or corrugated This would be more flexible and capable of contraction and uniform radial expansion.

Another representation of a system that has a distal protection system with a double filter according to the Invention is indicated in Figures 12-16.

In Figures 12-14, a tube circularly cylindrical (150) is formed to have, in a end (here is its distal end), a distal filter monolithic or one piece that has a tubular conical shape with a pattern of grooves that have been practiced on the surface of the tube (150) by cutting, roughing, chemical attack or any other technique. The tube (150) can be made of any material, such as metal or polymer, and especially nitinol with super elastic properties. The tube (150) can be the long enough to be used as a guide rail for catheters that are used for the procedure of stent angioplasty / placement.

At the distal end of the tube (150), the grooves are cut so that a filter is formed that has a expandability of at least a factor of 4. for example the tube (150) is made of nitinol, the expanded form can be programmed in memory by an applied heat treatment while the material is maintained in the desired expanded form, shown in Figures 13 and 14, by some tool containment. This is a known technique called adjusting the shape ("shape setting").

The grooves cut at the distal end of the tube (150) leave fine groups, circularly curved and circumferential of distal bands (110) and groups of bands intermediate (130, 131, 132). These strips are connected to, and interconnected by strut groups (120, 140, 141, 142) more thick, extending longitudinally and radially and that end up on the continuous surface (i.e. not perforated) of tube (150). When the expansion occurs for the adjustment of the shape, the struts (120, 140, 141, 142) are folded out giving the distal part of the tube (150) a conical shape. The Thinner bands (110, 130, 131, 132) are deformed to take circular arrangements during shape adjustment.

The tube (150) can have a length enough so that its proximal end (not shown) protrudes of the patient's body where the surgeon can handle it. He tube (150) can also be shorter and fixed to a wire of separate guide to save costs or to reduce the diameter over most of the length.

The geometry of the bands and struts is chosen so that deformation during shape adjustment and during expansion / contraction remain below limits acceptable. If necessary, the cutting pattern of the bands may include some solid hinges, which are about preferred bending points created by the thickness locally reduced material. In this way, it is also possible to cause a correct bending of the bands when the filter is forced to return to the cylindrical shape after the conical shape adjustment.

In Figure 12, the filter at the distal end of the tube (150) appears in its bent or radially state compressed, as it would appear when installed in the case (1) of the Figure 1. Figures 13 and 14 show the final shape of the filter after shape adjustment and after deployment from the cover (1). The distal bands (110) create a non-traumatic edge with a smooth series of tangential connections between the struts (120). The series of bands (130, 131, 132) connect the struts long (120, 140, 141, 142) with each other in different positions intermediate, but in principle the intermediate bands (130, 131, 132) could be omitted, at least if there is a sufficient number of longitudinal struts (120, 140-142) to create the desired fine mesh. However, the viable number of punctual It is limited by the following parameters:

The diameter of initial tube;

The width minimum of each slot, determined by the tooling;

The width minimum required for a stable prop; Y

The relationship of desired expansion determined by the acceptable length of each strut.

If the pores of the filter, constituted by the Slots are not thin enough, because the open area between the struts of an expanded filter is too large, additional groups of circumferential bands can be provided so that the mesh is thinner. The number of bands can be freely chosen because they do not influence the relationship of expansion. For the sake of clarity, only four rows of bands are indicated in Figures 12-14. As you can see, The length of the bands changes from proximal to distal. For example, the bands (130) are longer than the bands (131, 132).

Figure 14 shows a top view of the expanded filter where the shape of the bands (110) has been adjusted to create a uniform edge that can cover perfectly the entire cross section of an artery with a good fit.

The conical filter shown in the Figures 12-14 is intended to be used in combination with a supply case, as described here with reference to Figure 1. Said cover can cover the surface of the tube (150) and if the cover is retracted, the filter will assume the shape conical shown in Figures 13 and 14, which is substantially the same as the shape of Figure 1. When said cover of supply, surrounding a folded filter, is introduced into a artery and then gently removed, the filter will open, it will will widen and completely obstruct the cross section of the artery. Nitinol is an excellent material for such a filter, because it can withstand high elastic stresses. A filter of Nitinol according to this design can be deployed and folded elastically several times without any plastic deformation, while the known filter materials would fail.

In Figure 15 a pair is used in combination of filters (160, 190) with the shape indicated in the Figures 12-14 according to the invention, in order to catch piston particles between them for removal of the artery.

During most of a procedure stent angioplasty / placement, only the filter (160) more distal is placed. During angioplasty / placement of "stent" of the artery (170), piston particles (180) can be released from the site of the injury and circulate with the bloodstream until they are stopped by the filter (160). To the end of the procedure, a second filter (190) is displaced on the wire or tube (200) that is connected to the filter (160). The diameters of the distal ends of the filters (160, 190) they are approximately the same, and the filter (190) can be completely displaced on the filter (160), when it is supplied from its own supply case (not shown). He filter (190) has its own tube (210), which has a diameter inside much larger than the outside diameter of the wire or tube (200) of the first filter (160). The lumen between both tubes (200, 210) can be used for washing / vacuuming. Obviously this It can also be done through the tube (200).

Figure 16 shows the system of Figure 15, with the thickness dimensions of the various components illustrated more clearly, at one point in a fair procedure after the second filter (190) has been placed in a position to accommodate the first filter (160), with the ends distal of both filters in contact with each other. The angles of opening of both filters can be identical or, as shown, different. In case they are identical, the surfaces of both filters will match perfectly and all waste will remain caught, like in a sandwich, between the two surfaces conical

However, if the cone of the second filter (190) has an opening angle smaller than the filter (160), as sample, the situation indicated in Figure 16 will occur. distal edges of both filters fit well together but in as for the rest there is a gap between the surfaces of both filters This hole creates a chamber (220), in which small particles can move freely. The advantage of this provision is that the particles can be removed from the chamber (220) by aspiration through the lumen (230) between tubes (200, 210).

Figure 16 also shows a sheet of Additional filter (240) used to capture fine particles through the holes in the filter (160). The holes in the filter (160) can for example have a maximum size of 250 um, while the filter sheet (240) may be provided of holes or pores having a size of the order of only 150 \ mum or less, depending on the application.

The filter sheet (240) can be made of a sheet of thin metal, a polymer or any other fabric flexible and can be fixed to the distal bands (110) of the filter (160) by means of glue, points or by any other means. In its proximal limb, corresponding to its center, the blade (240) may have a central connection point (250) that is connected to a long wire (260) that runs completely through the tube (200) to a place outside the patient's body. With this wire (260), the filter sheet (240) can be stretched to a conical configuration before the filter (160) is brought to Your supply case (not shown). This makes it easy to put the filter (160) and the filter (240) in a uniform folded state. One time deployed or expanded the filter (160), the wire (260) can be released a little to allow the filter sheet (240) to separate from the filter (160), thereby creating an additional space to trap the small particles (181) that fit through the filter holes (160). The largest particles (182) do not they will pass through the filter (160) and remain on the proximal side of this filter If the chamber (220) between the conical surfaces of the filters (160, 190) is large enough, and if the wire (260) of the filter sheet (240) is not too tight, the Most particles can be easily aspirated through the lumen (230). If the wire (260) is stretched, the particles (181) they will be forced to move in the direction of the opening of aspiration. This is another advantage of using a filter sheet (240) movable.

Finally, only some very large particles they will remain in the chamber (220) and can be removed keeping them trapped between the filter surfaces, while both filters are removed to the supply case and the filters are compressed or folded to their configurations cylindrical This is done while applying an aspiration. keep going.

In case large particles are crushed, they break and slide through the holes in the filter (160), they will be gathered again in the filter sheet (240). Eventually, the wire (260) can be released a little more if there is a lot of material between the filter (160) and the filter sheet (240). In that case, the filter sheet (240) may appear to be a bag, full of material, hanging on the distal side of the filter (160) fully collapsed. This bag may not be removed at inside the supply case, but it will simply be removed of the artery while hanging from the distal tip of the sheath.

An important advantage of this double design filter is that upon compression of the filter cones, the Plunger particles can only leave the chamber (220) through of the suction lumen (230) or remain there to be finally mechanically trapped between cone surfaces or remain in the bag.

The distal filter will be placed throughout the entire stent angioplastial placement procedure and so Both mesh size is very important. An additional tip, of pressure-measurement and distally in the torrent blood, can control perfusion. The wire that holds is tip can be integrated with the wire (260) that is controlling the filter sheet (240). Alternatively, the wire (260) may have the form of guide wire (2) shown in the Figure 1, with a lumen connected to a pressure detector.

On the other hand, the filter (190) is only used for a short time and therefore its mesh size can be even finer than the filter (160).

In general, filter systems agree with the invention they can present many embodiments, including systems that contain a distal filter with or without a Additional filter mesh with a proximal filter, also with or without An additional filter sheet. Similarly, the relative position The filter and filter sheet may vary. The blade can be out of the filter (160). Other embodiments may be combinations of devices to capture plungers, being the devices of different geometries and / or types. Filters, balloons and Sponges of all kinds can be used in multiple combinations, all based on the entrapment principle full of particles before the protection device is fold when removed from the patient's body. Combinations of an inflatable supply sheath according to the invention with a multi-filter arrangement, as described, they can also be an embodiment of this invention.

Figures 17-27 illustrate the successive structure and phases in the use of another embodiment of the invention that is suitable for performing methods of angioplasty while catching and removing waste produced by the procedures.

Figure 17 also shows an artery (302) with an obstruction (304), or place of injury, that reduces the effective diameter of the artery (302). The invention can be used to treat virtually any artery in the body, such as the internal carotid artery where the emboli are extremely dangerous because the particles can cause a cerebrovascular accident.

A first component of this embodiment it is a guide wire (306) that, in a first step of a procedure that uses this embodiment, is done move through the artery (302), usually in the direction of the blood flow and beyond the site of injury (304). The pressure blood in the artery (302) adjacent to the distal end of the guide wire (306) can be monitored by a device to monitor the pressure that includes a pressure sensor miniature (310), or transducer, at the distal end of the wire guide (306) and a signal measuring unit at the end proximal, as represented by the element (5) in the Figure 1. The guide wire (306) may be provided with a lumen longitudinal that may contain wires or an optical fiber to transmit electrical or optical signals from the sensor (310) to the signal measurement unit, and the signal measurement unit it can be connected to an indicator, screen and / or device conventional alarm The sensor (310) can be, for example, a miniature distal dynamometric sensor, possibly of the type which has a load dependent electrical resistance. He pressure monitoring device can monitor continuously blood pressure in the artery (302) throughout The procedure.

Figure 18 shows the second step in which a guide catheter (312), or sheath, with a longitudinal lumen that transports a means of distal protection (314) is carried on the guide wire (306) until the medium (314) reaches a location that is distally, or downstream, of the place of the injury (304). If the distal protection means (314) is a filter  Made with a small shaved nitinol tube, it can be carried on the guide wire (306) while being retained in the lumen that It extends through the catheter (312).

The distal protection means (314) can be a filter, as described above, or a blocking balloon, or possibly a compressible sponge element. For example, him medium (314) can be an expandable filter cone, or umbrella, which It has the form described above, and it is deployed and fold back as described, with reference to the Figures 1-14 and in particular to the Figures 12-14, maintained in this crushed state within the  catheter (312). If the distal protection means is a balloon, it will be connected to an inflation lumen formed in or transported by the catheter (312).

In the next stage, described in Figure 19, the distal protection means (314) is deployed until it is extends completely through the flow path blood defined by the artery (302) in order to trap all the piston particles that may have been released from the site of the injury in the next steps of the procedure. The middle of protection (314) will remain in place until the end of process.

Figure 20 shows the next step in which a pre-dilatation catheter (320) is introduced on the guide catheter (312). The predilatation catheter (320) it carries, at its distal end, a predilatation balloon (322). He Predilation catheter (320) can be advanced over the guide catheter (312) and has several purposes. First, the predilatation balloon (322) can be used to extend the Inner diameter of the lesion (304) to create sufficient space to place a post-dilation device (326) in the form of a sheath that carries an inflatable balloon part (328). The part (328) can, if desired, carry a "stent" (332) that is initially in a contracted state radially, or folded. In addition, the distal tip of the catheter (320) with the balloon (322) it can act as an internal support for the postdilation balloon (328). The inner wall of the device (326) constitutes a supply sheath within which the self-expanding stent (332) is retained before of the deployment and from which the "stent" (332) can be pushed by any conventional means of supply (no shown). Said means of supply for stents self-expandable can be of any type, by example, a wire-pusher that pushes against the proximal side of the stent to remove it from the sheath.

Figure 21 shows the next step in which the predilatation balloon (322) has been deflated and displaced in distal direction or downstream. The stent self-expanding (332) has been removed from the cover of supply (326). Normally, a supply case only it serves to take a "stent" in its compressed state to the place of the lesion and keep it compressed until it has to be unfolded. This case usually has a cylindrical shape and when it supplies the stent it goes back while the "expandable stent" leaves the tip distal of the supply case. The cover is removed to continuation of the patient's body. The stent can have enough radial expansion force to fully open in the site of injury, but often this force is insufficient and the stent will remain in some intermediate position semi-deployed A stent self-expandable can be manufactured with different types of materials, for example nitinol. Nitinol is a material with mechanical hysteresis and the force needed to fold the stent is much greater than the radial force exerted by the "stent" in the deployment. This means that a stent nitinol self-expandable can be what strong enough to contain an open artery but can need some help for your total deployment. This help can come from the post-dilatation balloon (328).

Figure 22 shows the next stage in al that the sheath (326) is used to help deploy the "stent" (332). The distal end of the sheath (326) with a Balloon part (328) can be inflated through a lumen (not shown) on the wall of the case. First the supply case (326) moves again and the part of the balloon (328) is aligned with the "stent" (332) in the area of the lesion (304). Inflation from the part of the globe (328) will now cause a new expansion of the "stent" (332). However, the inner wall of the case (326) that contained the "stent" (332) before delivery can crush under the high pressure that may be necessary to fully deploy the stent (332). Therefore the balloon Predilation (322) can be inflated to be used for create a stiffer inner support for the case (326). Aligning both sections of the globe, as shown in Figure 23, are created a double concentric balloon segment, which is enough strong for post-dilation.

Figure 24 shows the next step in which the stent (332) is fully deployed by the forces combined balloon (322) and part of the balloon post-dilatation (328), despite the forces contrary to the artery wall at the site of injury (304) which has now become a larger opening. If the medium distal protection (314) is a balloon and if the part of the balloon (328) causes a full proximal occlusion, a camera is created closed (336) in the artery (302) between the balloon (314) and the part of the globe (328).

Figures 25 and 26 show the next step in which the predilatation catheter (320) has been removed, leaving the balloon part (328) inflated in volume to the cover supply (326). Although the internal support of the case (326) has been removed, the inflated part of the balloon (328) can be used easily for proximal occlusion means, because the pressure can be much lower than for postdilation of the lesion and stent deployment. The cover (326) that previously held the "stent" (332) can now be used as a working channel, for example, for washing and aspiration. This working channel is in open connection with devices outside the patient's body and can be used for a series of procedures in the camera closed (336) between the balloon (314) and the balloon portion (328). A advantage of this closed chamber is that it can be washed with a clear solution capable of dissolving the plate, without assuming a danger to the body parts downstream. These Compositions are known in the art. After washing with a clear fluid the artery wall in the chamber region, can be inspected with an endoscope or an optical fiber. It allows clear visual inspection in a closed compartment of the artery including inspection of the surface of the "stent" While monitoring the pressure behind the distal occlusion device, this way of working is safe.

If desired, the suction tube (326) / sheath Inflatable supply can be deflated, removed until is close to the stent section and then inflated again to allow for additional washing, aspiration and inspection, while the distal occlusion device (314) remains in place.

For the supply of washing fluid, you can make a separate lumen on the wall of the supply case (326), that goes to the distal end of this sheath (no shown). Other procedures in a temporarily closed chamber of an artery include ultrasound treatment, radiotherapy and supply of medicines, among others.

Figure 27 shows a final step in which the part of the post-dilatation balloon (328) has been deflated and the middle Distal protection (314) has been crushed. The final step can be the withdrawal of all devices from the patient's body, except, obviously, the "stent" (332), which can be left there.

As explained above, the number of Longitudinal struts is limited based on the desired expansion ratio. The distance between two bands circumferential can be made quite small, but they have to be able to remain folded in order to obtain a device Crush and expandable. Therefore a certain gap must be left between them. Normally said gap would be greater than 50 µm, of so an additional filter is needed in case the size of particle allowed be 50 µm, as to be used as filter in a carotid artery.

Claims (13)

1. System to prevent embolism and micro-embolism in a vascular system, adapted to be introduced into a patient's blood vessel, said system comprising radially expandable filter elements from a closed state to an open state, characterized in that The filter arrangement includes:
-
a first element and a second filter element with a surface structured filter to prevent the passage of particles and allow the passage of blood,
-
where said first filter element (4, 44, 102, 160) has millipores and is coupled to a first elongated displacement element (2, 200) to move said first filter element,
-
where said second filter element (14, 190) is coupled to a second displacement element (12, 210) to displace said second filter element (14, 190),
-
a first cover (1) surrounding said first displacement element (2) to position the first filter element (4) in its state closed at its desired location inside the vessel blood, said first filter element (4) being able to be extracted from said first sheath (1) to unfold radially until its open state by using said first element of displacement (2),
-
a second sheath (10, 170) surrounding the displacement elements (2, 200; 12, 210) to position the second filter element (14, 190) in its closed state at its desired location in the inside the blood vessel, said second element being able to filter (14, 190) be removed from said second sheath (10) to deploy radially to its open state by using said second displacement element (12, 210),
where at least one of said filter elements it can be moved inside said second case (10) to radially contract at least one of said filter elements until its closed state.
2. System according to claim 1, characterized in that each of said filter elements has a concentric outer edge with said support element.
3. System according to claim 2, characterized in that at least one of said filter elements comprises a frame (22, 24, 26; 32, 34, 36; 46, 48) of an elastically deformable material and a sheet of a filter material (28; 38) fixed to said frame and which supplies said filter surface.
System according to claim 3, characterized in that at least one of said filter elements has a generally conical or flared shape with a vertex, said vertex being located adjacent to said support element.
5. System according to claim 3, characterized in that the frame material is an expandable metal with shape memory, and that said frame is formed to be in an unstressed state when said one of said filter elements is in its open state
6. System according to claim 5, characterized in that said frame is formed by shape adjustment.
7. System according to claim 5, characterized in that the shape memory metal is nitinol.
System according to claim 5, characterized in that said support element has two opposite ends and a lumen extending between said two ends, and in that said system further comprises a pressure sensor in communication with the lumen at one of said extremes.
9. System according to claim 1, characterized in that at least one of said filter elements comprises a basket (102) of an elastically deformable material having pores sized to prevent the passage of particles and allow the passage of blood.
10. System according to claim 1, characterized in that:
-
sayings displacement elements have a distal end adapted to be introduced into the blood vessel and an adapted proximal end to be positioned outside the patient when using the device;
-
saying first filter element is arranged next to said end distal of the first filter element; Y
-
saying second filter element is arranged next to said first filter element, and
-
after the completion step of a treatment, the first and second filter elements are approximate each other, radially contracting the first and second filter elements, and the first and second elements of Filter are removed from the blood vessel.
11. System according to claim 10, characterized in that said device is further adapted to perform an aspiration between the first and second filter elements at least after the step of carrying out a treatment.
12. System according to claim 1, characterized in that it further comprises means (5) for monitoring blood pressure in the vascular system.
13. System according to claim 1, characterized in that the second displacement element (12, 210) surrounds the first displacement element (2, 200).
ES01922337T 2000-03-10 2001-03-12 Vascular embolia prevention device using filters. Active ES2282246T3 (en)

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DE60126585T2 (en) 2007-12-06
EP1253871A2 (en) 2002-11-06
WO2001067989A3 (en) 2002-09-06
AT353604T (en) 2007-03-15
US20010044634A1 (en) 2001-11-22
WO2001067989A2 (en) 2001-09-20
US6485502B2 (en) 2002-11-26
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DE60126585D1 (en) 2007-03-29
EP1253871B1 (en) 2007-02-14

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